The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Series 7000/holter Recorder.
| Device ID | K851971 |
| 510k Number | K851971 |
| Device Name: | SERIES 7000/HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | PFIZER, INC. P.O. BOX 23181 8200 WEST TOWER AVENUE Milwaukee, WI 53223 |
| Contact | Thomas Massopust |
| Correspondent | Thomas Massopust PFIZER, INC. P.O. BOX 23181 8200 WEST TOWER AVENUE Milwaukee, WI 53223 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-06-20 |